Stanford Surgery Clinical Trials

Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma

The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP control.

The secondary objectives are to measure the changes in BCDVA, visual field, ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy, and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment.

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: Vehicle
  • drug: rhNGF

Eligibility


Inclusion Criteria:

   1. Patients 18 years of age or older. Participant must understand and sign the informed
   consent. If the participant's vision is impaired to the point where he/she cannot read
   the informed consent document, the document will be read to the participant in its
   entirety.

   2. Participant's clinical diagnosis must be consistent with glaucoma characterized by the
   following features: a) clinical evidence of progressive RGC dysfunction and
   degeneration using visual field and/or a structural modality. There must be at least 3
   reliable visual fields within 14 months prior to entering into the study; b) residual
   visual field preservation in at least 1 quadrant.

   3. Participant must be medically able to undergo the testing required in the flowsheet of
   exam procedures.

   4. Females of childbearing potential must agree to use an effective form of birth
   control.

Exclusion Criteria:

   1. Participant has another optic nerve or retinal degenerative disease or co-morbidity
   causing significant vision loss, irrespective of whether it is currently treated or
   untreated, that could limit the possibility of visual recovery.

   2. Participant is blind in one eye.

   3. Participant has a requirement of acyclovir and/or related products during study
   duration. 4- Participant has evidence of corneal opacification or lack of optical
   clarity.

   4. Participant has evidence of corneal opacification or lack of optical clarity.

   5. Participant has undergone lens removal in the last 3 months, with or without
   intra-ocular lens implantation, or has undergone intra-ocular lens replacement within
   3 months, or has undergone any other ocular surgery within 9 months prior to
   initiation of study drug.

   6. Participant is receiving systemic steroids or other immunosuppressive medications.

   7. Participant is currently participating in or has within the last 3 months participated
   in any other clinical trial of a non-clinically approved drug by ocular or systemic
   administration.

   8. Participant has uveitis or other ocular inflammatory disease.

   9. Participant has diabetic macular edema.

10. Participant has a history of ocular herpes zoster.

11. Participant is on chemotherapy.

12. Participant has a history of malignancy, not counting basal cell carcinomas, UNLESS it
   was treated successfully 2 years prior to inclusion in the trial.

13. Known hypersensitivity to one of the components of the study or procedural
   medications.

14. History of drug, medication or alcohol abuse or addiction.

15. Females of childbearing potential (those who are not surgically sterilized or post-
   menopausal for at least 1 year) are excluded from participation in the study if they
   meet any one of the following conditions:

      1. are currently pregnant or,

      2. have a positive result on the urine pregnancy test at the Screening/Baseline
      Visit or,

      3. intend to become pregnant during the study treatment period or,

      4. are breast-feeding or,

      5. not willing to use highly effective birth control measures, such as: Hormonal
      contraceptives - oral, implanted, transdermal, or injected and/or mechanical
      barrier methods - spermicide in conjunction with a barrier such as a condom or
      diaphragm or IUD during the entire course of and 30 days after the study
      treatment periods.

Ages Eligible for Study

18 Years - 90 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariana Nuñez
(650) 497-7846
I'm interested

Transplantation

Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma

The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP control.

The secondary objectives are to measure the changes in BCDVA, visual field, ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy, and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment.

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: Vehicle
  • drug: rhNGF

Eligibility


Inclusion Criteria:

   1. Patients 18 years of age or older. Participant must understand and sign the informed
   consent. If the participant's vision is impaired to the point where he/she cannot read
   the informed consent document, the document will be read to the participant in its
   entirety.

   2. Participant's clinical diagnosis must be consistent with glaucoma characterized by the
   following features: a) clinical evidence of progressive RGC dysfunction and
   degeneration using visual field and/or a structural modality. There must be at least 3
   reliable visual fields within 14 months prior to entering into the study; b) residual
   visual field preservation in at least 1 quadrant.

   3. Participant must be medically able to undergo the testing required in the flowsheet of
   exam procedures.

   4. Females of childbearing potential must agree to use an effective form of birth
   control.

Exclusion Criteria:

   1. Participant has another optic nerve or retinal degenerative disease or co-morbidity
   causing significant vision loss, irrespective of whether it is currently treated or
   untreated, that could limit the possibility of visual recovery.

   2. Participant is blind in one eye.

   3. Participant has a requirement of acyclovir and/or related products during study
   duration. 4- Participant has evidence of corneal opacification or lack of optical
   clarity.

   4. Participant has evidence of corneal opacification or lack of optical clarity.

   5. Participant has undergone lens removal in the last 3 months, with or without
   intra-ocular lens implantation, or has undergone intra-ocular lens replacement within
   3 months, or has undergone any other ocular surgery within 9 months prior to
   initiation of study drug.

   6. Participant is receiving systemic steroids or other immunosuppressive medications.

   7. Participant is currently participating in or has within the last 3 months participated
   in any other clinical trial of a non-clinically approved drug by ocular or systemic
   administration.

   8. Participant has uveitis or other ocular inflammatory disease.

   9. Participant has diabetic macular edema.

10. Participant has a history of ocular herpes zoster.

11. Participant is on chemotherapy.

12. Participant has a history of malignancy, not counting basal cell carcinomas, UNLESS it
   was treated successfully 2 years prior to inclusion in the trial.

13. Known hypersensitivity to one of the components of the study or procedural
   medications.

14. History of drug, medication or alcohol abuse or addiction.

15. Females of childbearing potential (those who are not surgically sterilized or post-
   menopausal for at least 1 year) are excluded from participation in the study if they
   meet any one of the following conditions:

      1. are currently pregnant or,

      2. have a positive result on the urine pregnancy test at the Screening/Baseline
      Visit or,

      3. intend to become pregnant during the study treatment period or,

      4. are breast-feeding or,

      5. not willing to use highly effective birth control measures, such as: Hormonal
      contraceptives - oral, implanted, transdermal, or injected and/or mechanical
      barrier methods - spermicide in conjunction with a barrier such as a condom or
      diaphragm or IUD during the entire course of and 30 days after the study
      treatment periods.

Ages Eligible for Study

18 Years - 90 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariana Nuñez
(650) 497-7846
I'm interested

Surgery

Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma

The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP control.

The secondary objectives are to measure the changes in BCDVA, visual field, ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy, and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment.

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: Vehicle
  • drug: rhNGF

Eligibility


Inclusion Criteria:

   1. Patients 18 years of age or older. Participant must understand and sign the informed
   consent. If the participant's vision is impaired to the point where he/she cannot read
   the informed consent document, the document will be read to the participant in its
   entirety.

   2. Participant's clinical diagnosis must be consistent with glaucoma characterized by the
   following features: a) clinical evidence of progressive RGC dysfunction and
   degeneration using visual field and/or a structural modality. There must be at least 3
   reliable visual fields within 14 months prior to entering into the study; b) residual
   visual field preservation in at least 1 quadrant.

   3. Participant must be medically able to undergo the testing required in the flowsheet of
   exam procedures.

   4. Females of childbearing potential must agree to use an effective form of birth
   control.

Exclusion Criteria:

   1. Participant has another optic nerve or retinal degenerative disease or co-morbidity
   causing significant vision loss, irrespective of whether it is currently treated or
   untreated, that could limit the possibility of visual recovery.

   2. Participant is blind in one eye.

   3. Participant has a requirement of acyclovir and/or related products during study
   duration. 4- Participant has evidence of corneal opacification or lack of optical
   clarity.

   4. Participant has evidence of corneal opacification or lack of optical clarity.

   5. Participant has undergone lens removal in the last 3 months, with or without
   intra-ocular lens implantation, or has undergone intra-ocular lens replacement within
   3 months, or has undergone any other ocular surgery within 9 months prior to
   initiation of study drug.

   6. Participant is receiving systemic steroids or other immunosuppressive medications.

   7. Participant is currently participating in or has within the last 3 months participated
   in any other clinical trial of a non-clinically approved drug by ocular or systemic
   administration.

   8. Participant has uveitis or other ocular inflammatory disease.

   9. Participant has diabetic macular edema.

10. Participant has a history of ocular herpes zoster.

11. Participant is on chemotherapy.

12. Participant has a history of malignancy, not counting basal cell carcinomas, UNLESS it
   was treated successfully 2 years prior to inclusion in the trial.

13. Known hypersensitivity to one of the components of the study or procedural
   medications.

14. History of drug, medication or alcohol abuse or addiction.

15. Females of childbearing potential (those who are not surgically sterilized or post-
   menopausal for at least 1 year) are excluded from participation in the study if they
   meet any one of the following conditions:

      1. are currently pregnant or,

      2. have a positive result on the urine pregnancy test at the Screening/Baseline
      Visit or,

      3. intend to become pregnant during the study treatment period or,

      4. are breast-feeding or,

      5. not willing to use highly effective birth control measures, such as: Hormonal
      contraceptives - oral, implanted, transdermal, or injected and/or mechanical
      barrier methods - spermicide in conjunction with a barrier such as a condom or
      diaphragm or IUD during the entire course of and 30 days after the study
      treatment periods.

Ages Eligible for Study

18 Years - 90 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariana Nuñez
(650) 497-7846
I'm interested